QVAR REDIHALER

Product NDC: 53002-2436
11-digit product format: 530022436
Labeler code: 53002
Product ID: 53002-2436_67896974-da7b-4189-94f3-2f291147678d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Beclomethasone Dipropionate HFA
Dosage form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA207921
Marketing category: NDA
Marketing start: 2018-02-15
Marketing end: 0000-00-00
Substance: BECLOMETHASONE DIPROPIONATE
Active strength: 40 ug/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53002-2436		I	Inactivated by FDA		2026-08-11
excluded package	package	53002-2436	53002-2436-3	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2436-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2436-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2436-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2436-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2436-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2436-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2436-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2436-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2436-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-2436-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-2436-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207921-001	QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE	0.04MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2017-08-03
N207921-002	QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE	0.08MG/INH	AEROSOL, METERED / INHALATION		RLD, RS	2017-08-03

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N207921-001	8132712	2028-09-07	Drug product, Delist requested	2017-08-28
N207921-001	10022509	2031-05-18	Drug product, Delist requested	2018-08-13
N207921-001	10022510	2031-05-18	Drug product, Delist requested	2018-08-13
N207921-001	10086156	2031-05-18	Drug product, Delist requested	2018-10-16
N207921-001	10695512	2031-05-18	Drug product, Delist requested	2020-07-28
N207921-001	11395889	2031-05-18	Drug product, Delist requested	2022-08-19
N207921-001	8931476	2031-07-17	Drug product	2017-08-28
N207921-001	10561808	2032-01-01	Drug product, Delist requested	2020-03-19
N207921-001	11395888	2038-01-26	Drug product	2022-08-19
N207921-001	11793953	2038-01-26	Drug product	2023-11-13
N207921-001	12296089	2038-01-26	Drug product	2025-06-02
N207921-001	10792447	2039-01-25	Drug product	2020-10-29
N207921-001	11559637	2039-07-21	Drug product	2023-02-22
N207921-001	11957832	2041-05-05	Drug product	2024-05-07
N207921-001	11583643	2041-08-19	Drug product	2023-03-20
N207921-002	8132712	2028-09-07	Drug product, Delist requested	2017-08-28
N207921-002	10022509	2031-05-18	Drug product, Delist requested	2018-08-13
N207921-002	10022510	2031-05-18	Drug product, Delist requested	2018-08-13
N207921-002	10086156	2031-05-18	Drug product, Delist requested	2018-10-16
N207921-002	10695512	2031-05-18	Drug product, Delist requested	2020-07-28
N207921-002	11395889	2031-05-18	Drug product, Delist requested	2022-08-19
N207921-002	8931476	2031-07-17	Drug product	2017-08-28
N207921-002	10561808	2032-01-01	Drug product, Delist requested	2020-03-19
N207921-002	11395888	2038-01-26	Drug product	2022-08-19
N207921-002	11793953	2038-01-26	Drug product	2023-11-13
N207921-002	11865247	2038-01-26	Drug product, Delist requested	2024-01-23
N207921-002	11896759	2038-01-26	Drug product, Delist requested	2024-03-11
N207921-002	12296089	2038-01-26	Drug product	2025-06-02
N207921-002	10792447	2039-01-25	Drug product	2020-10-29
N207921-002	11559637	2039-07-21	Drug product	2023-02-22
N207921-002	11957832	2041-05-05	Drug product	2024-05-07
N207921-002	11583643	2041-08-19	Drug product	2023-03-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2017-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2017-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207921-001	QVAR REDIHALER	0.04MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207921-002	QVAR REDIHALER	0.08MG/INH	AEROSOL, METERED / INHALATION	RLD	2017-08-03	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 972 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207921-001	8132712	2028-09-07	Drug product, Delist requested	2017-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	10022509	2031-05-18	Drug product, Delist requested	2018-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	10022510	2031-05-18	Drug product, Delist requested	2018-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	10086156	2031-05-18	Drug product, Delist requested	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	10695512	2031-05-18	Drug product, Delist requested	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	11395889	2031-05-18	Drug product, Delist requested	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	8931476	2031-07-17	Drug product	2017-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	10561808	2032-01-01	Drug product, Delist requested	2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	11395888	2038-01-26	Drug product	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	11793953	2038-01-26	Drug product	2023-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	12296089	2038-01-26	Drug product	2025-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	10792447	2039-01-25	Drug product	2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	11559637	2039-07-21	Drug product	2023-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	11957832	2041-05-05	Drug product	2024-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-001	11583643	2041-08-19	Drug product	2023-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	8132712	2028-09-07	Drug product, Delist requested	2017-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	10022509	2031-05-18	Drug product, Delist requested	2018-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	10022510	2031-05-18	Drug product, Delist requested	2018-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	10086156	2031-05-18	Drug product, Delist requested	2018-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	10695512	2031-05-18	Drug product, Delist requested	2020-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11395889	2031-05-18	Drug product, Delist requested	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	8931476	2031-07-17	Drug product	2017-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	10561808	2032-01-01	Drug product, Delist requested	2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11395888	2038-01-26	Drug product	2022-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11793953	2038-01-26	Drug product	2023-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11865247	2038-01-26	Drug product, Delist requested	2024-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11896759	2038-01-26	Drug product, Delist requested	2024-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	12296089	2038-01-26	Drug product	2025-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	10792447	2039-01-25	Drug product	2020-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11559637	2039-07-21	Drug product	2023-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11957832	2041-05-05	Drug product	2024-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207921-002	11583643	2041-08-19	Drug product	2023-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	8132712	2028-09-07	Drug product, Delist requested	2017-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	10022509	2031-05-18	Drug product, Delist requested	2018-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	10022510	2031-05-18	Drug product, Delist requested	2018-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	10086156	2031-05-18	Drug product, Delist requested	2018-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	10695512	2031-05-18	Drug product, Delist requested	2020-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	11395889	2031-05-18	Drug product, Delist requested	2022-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	8931476	2031-07-17	Drug product	2017-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207921-001	10561808	2032-01-01	Drug product, Delist requested	2020-03-19	`31067a03dcf5…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
56560def-9e4f-4cea-995d-33e9e282a050	Product name	1	20171204
7cc1653a-dc36-45c2-8752-61a7a3967d75	Product name	1	20170829
e97c5025-cafa-043f-50a3-771ab2b84660	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	These highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER ® (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1976
2023-06-07	These highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER ® (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1976
2023-01-30	These highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER ® (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1976
2020-12-15	These highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER ® (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1976
2020-01-31	These highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER ® (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-2436-3	QVAR REDIHALER	1 in 1 CARTON	AEROSOL, METERED	1		8
53002-2436-3	QVAR REDIHALER	1 in 1 INHALER	AEROSOL, METERED	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2436	QVAR REDIHALER (BECLOMETHASONE DIPROPIONATE HFA) AEROSOL, METERED [RPK PHARMACEUTICALS, INC.]	8	Legacy NDC, 2 package rows	20230609_9fb78667-7db9-4d98-b8a2-0de60458de11.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE HFA	Teva Respiratory, LLC	cada897a-264e-450d-ae00-36e7fe747080	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207921 application number: NDA207921
QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE HFA	A-S Medication Solutions	ccd3aaec-4892-40d0-ad60-3e570178fbe1	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207921 application number: NDA207921
QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE HFA	A-S Medication Solutions	6c19254b-6333-46fa-835b-16b48df57bdd	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207921 application number: NDA207921
QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE HFA	A-S Medication Solutions	2814cf81-392e-4dd4-9816-ae7e6e5ec84f	2023-09-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207921 application number: NDA207921

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5B307S63B2	BECLOMETHASONE DIPROPIONATE	5534-09-8	BECLOMETHASONE DIPROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1998773	beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	PSN	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998771	beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	PSN	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998774	QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	PSN	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998772	QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	PSN	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998774	Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler [Qvar]	SBD	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998772	Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler [Qvar]	SBD	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998773	Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.04 MG/ACTUAT Metered Dose Inhaler	SCD	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998771	Breath-Actuated 120 ACTUAT beclomethasone dipropionate 0.08 MG/ACTUAT Metered Dose Inhaler	SCD	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998773	beclomethasone dipropionate 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	SY	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998771	beclomethasone dipropionate 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	SY	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998774	Breath-Actuated 120 ACTUAT Qvar 0.04 MG/ACTUAT Metered Dose Inhaler	SY	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998772	Breath-Actuated 120 ACTUAT Qvar 0.08 MG/ACTUAT Metered Dose Inhaler	SY	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998774	QVAR Redihaler 40 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	SY	9fb78667-7db9-4d98-b8a2-0de60458de11	8
1998772	QVAR Redihaler 80 MCG/ACTUAT Breath-Actuated Metered Dose Inhaler, 120 ACTUAT	SY	9fb78667-7db9-4d98-b8a2-0de60458de11	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2436-3	53002243603	1 INHALER in 1 CARTON (53002-2436-3) > 1 AEROSOL, METERED in 1 INHALER	1 inhaler	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QVAR REDIHALER - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	8